• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Product Classification

  • Print
  • Share
  • E-mail
New Search Back To Search Results
Device prosthesis, hip, hemi-, acetabular, cemented, metal
Regulation Description Hip joint (hemi-hip) acetabular metal cemented prosthesis.
Definition Call for PMAs 12/26/96 (61 FR 50710 (9/27/96))
Regulation Medical Specialty Orthopedic
Review Panel Orthopedic
Product CodeKWB
Premarket Review Office of Device Evaluation (ODE)
Division of Orthopedic Devices (DOD)
Joint and Fixation Devices Branch Two ¿ Hips/Wrists/Fingers (JFDB2)
Submission Type PMA
Regulation Number 888.3370
Device Class 3
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Recognized Consensus Standards
Implanted Device? Yes
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible